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Service-Only Providers and ISO 13485

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Guest user Created:   Jan 06, 2020 Last commented:   Jan 07, 2020

Service-Only Providers and ISO 13485

This ISO always refers to "medical device manufacturers." XYZ and numerous other independent service providers do NOT manufacture, but we repair and maintain medical equipment. In your nomenclature, "service provision" is always coupled with "production." How does a service-only provider gain ISO13485 certification exclusive of the manufacturing provisions? Is this ISO even appropriate given that XYZ is NOT a manufacturer? We are in the early stages of seeking counsel on the project, and we want to get it right.

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Jan 07, 2020

Service-only providers gain ISO 13485:2016 certificate for their part of the process. It means that some requirements from clause 7.5 won't be applicable. For example, 7.5.2 Cleanliness of product, 7.5.3 Installation activities (if your service does not cover this), 7.5.5 Particular requirements for sterile medical devices, 7.5.7 Particular requirements for validation of processes for sterilization and sterile barrier systems, 7.5.9.2 Particular requirements for implantable medical devices. For other clauses, you will just replace the word production with service. For example, clause 7.5.1 Control of production and service provision in your system will be 7.5.1 Control of service provision; clause 7.5.6 Validation of processes for production and service provision in your system will be 7.5.6 Validation of processes for service provision.

According to the ISO 13485:2016, section 3 Terms and definitions, in point 3.15 is defined that there are four generic product categories and one of it is service. Service is the result of at least one activity necessarily performed at the interface between the supplier and customer and is generally intangible. Provision of a service can involve, for example, the following: an activity performed on a customer-supplied tangible product (e.g. automobile to be repaired); an activity performed on a customer-supplied intangible product (e.g. the income statement needed to prepare a tax return);  the delivery of an intangible product (e.g. the delivery of information in the context of knowledge transmission); the creation of ambiance for the customer (e.g. in hotels and restaurants).

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Dick Herrick Jan 07, 2020

Thanks for taking the time to respond in detail.  I appreciate it.

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Jan 06, 2020

Jan 07, 2020

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